EMS117h
Study: Only 25% of pulse oximeters tested for skin-tone bias post-FDA guidance
These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, leading to potential health risks for non-white patients, the study states ...
EurekAlert!1d
Pulse oximeters infrequently tested by manufacturers on diverse sets of subjects
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...
TCTMD2d
FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
healthday3d
FDA Drafts New Recommendations for More Inclusive Pulse Oximeter Testing
The U.S. Food and Drug Administration released draft guidelines on Jan. 6 proposing that manufacturers conduct larger, ...
Johnny Jet on MSN3d
Why you should add these 8 health items to your toiletry bag when you travel
If you're traveling this winter, the best thing you can do is be prepared in case you get sick on the road. Here's what you ...
STAT4d
FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar ...
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...